Kornimate/medical-research-clean huggingface dataset:
pembrolizumab (mk-3475) plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin for first-line advanced and/or unresectable biliary tract carcinoma (btc) (mk-3475-966/keynote-966)

Conditions: Biliary Tract Carcinoma

Summary: this is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma. the primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (os).


Eligibility criteria:
inclusion criteria * has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer) * has measurable disease based on response evaluation criteria in solid tumors (recist 1.1), as determined by the site investigator * participants with a history of hepatitis b or hepatitis c can be enrolled if they meet study criteria * is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion * has a life expectancy of greater than 3 months * has adequate organ function exclusion criteria * has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer) * has ampullary cancer * has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasms * has received prior therapy with an anti-programmed cell death 1 (anti-pd-1), anti- programmed cell death ligand 1 or 2 (anti-pd-l1, anti-pd-l2) agent or with an agent directed to another stimulatory or coinhibitory t-cell receptor (e.g., cytotoxic t-lymphocyte-associated protein 4 \[ctla-4\], ox-40, cd137) * has a known history of, or any evidence of, central nervous system (cns) metastases and/or carcinomatous meningitis, as assessed by local site investigator * has had an allogenic tissue/solid organ transplant

Keywords: programmed cell death 1 (pd-1) pembrolizumab cholangiocarcinoma gallbladder cancer checkpoint inhibitor immunotherapy biliary keytruda bile duct cancer
rosiglitazone versus rosiglitazone and metformin versus rosiglitazone and avandia in the treatment of nonalcoholic steatohepatitis (nash)

Conditions: Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver Disease

Summary: the purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven nonalcoholic steatohepatitis (nash). this study was designed to answer the question: are there differences in the efficacy (as measured by histopathology and insulin resistance) of three different therapeutic modalities used to treat nash?


Eligibility criteria:
inclusion criteria: 1. patients between 18-70 years old 2. negative urine pregnancy test in females 3. history of elevated liver associated enzymes (alt \> 40) 4. liver biopsy within 1 year of screening in this study that shows histopathologic findings consistent with nash exclusion criteria: 1. alt greater than three times normal 2. nyha class 3 or 4 heart failure 3. any congestive heart failure patient on insulin 4. patients on one of the 3 study drugs within the past 3 months prior to enrollment 5. alcohol consumption \>20 gm/day in a female and \> 30 gm/day in a male 6. evidence of co-existent chronic liver disease to include viral hepatitis, wilson's disease, autoimmune hepatitis, hemochromatosis, primary biliary cirrhosis, or primary sclerosing cholangitis 7. serum creatinine on initial screening of greater than 1.4 8. known hypersensitivity to rosiglitazone, metformin, or losartan 9. known history of diabetic ketoacidosis 10. female that is breastfeeding 11. insulin dependent diabetic

Keywords: nonalcoholic steatohepatitis (nash) fatty liver insulin resistance
evaluation of an endoscopic suturing system for tissue apposition in colonic polypectomy

Conditions: Polyps

Summary: the purpose of this study is to show that the surgical site in the bowel wall can be sewn closed in the colon or intestine, with a new sewing device after removal of a benign polyp according to standard of care.

polypectomy is the medical term for removing polyps. polyps are abnormal like growths that protrude into the lining of the bowel. because a polyp cannot always be removed by a snare, the usual and simplest method, (for example, it may be too flat), a doctor (colorectal surgeon) may perform a polypectomy using a technique called endoscopic mucosal resection (emr). endoscopic mucosal resection (emr)is based on the concept that endoscopy (looking at the inside of your colon with an instrument called a colonoscope) provides visualization and access to the innermost lining of the gastrointestinal tract, where a polyp originates. the endoscopic mucosal resection (emr)performed during this study will be standard of care according to the current practice at university hospitals of cleveland. following polyp removal, the study procedure will be performed. a medical device is being evaluated to help with this procedure by closing the wound that remains after the polyp is removed without performing an open surgical operation. this involves suturing (sewing) the tissue back together with a tissue apposition system (tas). this is also called tissue approximation. the sewing device being evaluated has been cleared by the food and drug administration (fda). up to 20 men and women, at least 21 years of age, requiring removal of a colonic or rectal polyp that cannot be removed by traditional colonic polypectomy, will be asked to enroll in the study. following polyp removal, these patients will have the remaining tissue area closed using the study sewing device. participation in this study will last approximately three months.

Eligibility criteria:
inclusion criteria: * at least 21 years of age; * willing to give consent and comply with evaluation and treatment schedule; * approved for polypectomy per standard preoperative endoscopic evaluation; * established indication for a procedure greater than colonoscopy and colonic polypectomy. this will include polyps not suitable for current practice (snare procedure) endoscopic resection by nature of size or location, in which an intestinal resection, laparoscopic-assisted polypectomy is required; * surgical area viewable with laparoscopy. exclusion criteria: * physical or psychological condition which would impair study participation; * unable or unwilling to attend follow-up visits and examinations; * concurrent surgical procedure; * pregnancy; * a polyp which appears to be an invasive cancer, even with negative pathology; * a polyp with biopsies suspicious for invasive cancer; * participation in any other investigational device or drug study within 30 days prior to enrollment; or * any condition which precludes compliance with the study.

Keywords: colon rectum polyp emr established indication for a procedure greater than colonoscopy and colonic polypectomy
analyzing the relationship between speed propofol is given and low blood pressure

Conditions: Hypotension on Induction

Summary: the objective of this study is to evaluate the hemodynamic changes related to propofol administration rate. we hypothesize that slow administration of iv propofol will have less hemodynamic disturbances and will require less amount of vasoactive medication for bp correction when compared to standard fda approved administration rate.


Eligibility criteria:
inclusion criteria: * any patient from 18 till 80 years of age * patient undergoing non-cardiac elective surgery * duration of the surgery longer than one hour * native/fluent english speaker * patients whose staff anesthesiologist planned to use propofol as a primary anesthetic for induction exclusion criteria: * any patient admitted for non-elective surgery * any patient undergoing cardiac surgery * any patient under 18 years of age * any patient older than 80 years of age * any patient with history of severe heart disease (chf with significant limitations of activity due to sever symptoms, prior heart surgery, atrial fibrillation, etc.) * any patient with pre-operative hemodynamic instability (e.g. sepsis, chronic kidney disease, liver cirrhosis) who requires constant or intermittent administration of vasoactive or inotropic medication to support vital signs (bp) * any patient on vasoactive or inotrop medications in early pre-operative period (within 24 hours prior to the surgery) * any patient who does not speak english or not fluently * any patient with cognitive impairment or mentally incapacitation * any pregnant or breastfeeding females * any patient whose staff anesthesiologist planned to use a primary anesthetic other than propofol
in silico trials of surgical interventions

Conditions: Cardiovascular Diseases

Summary: the project aims to establish a database of cardiovascular patients using hes and linked mortality data. this database will be used to model trials in silico with the aim of informing the design of future cardiovascular trials in the united kingdom.

routinely collected health data such as national health service hospital episode statistics (hes) contains a wealth of real-world longitudinal patient health data including demographics, diagnoses, procedures and other clinical information. these data can be used to address many of the existing challenges in the design and conduct of clinical trials by optimising trial design and simplifying the assessment of adherence, safety, and outcomes. when a trial concept is initiated, researchers may use hes data to explore the hypothesis and assess trial feasibility. the large-volume patient data enables a detailed understanding of the characteristics of the target patient populations and the estimation of the real-world treatment effects across different patient groups thus enabling identification of targeted populations for specific interventions. by tapping into this resource and using advanced statistical and machine learning methods, the investigators can emulate the trial and thus obtain the key trial parameters required for designing a clinical trial, minimise the number of assumptions imputed and make the design and development of clinical trials quicker, simpler, and more reliable.

Eligibility criteria:
- the target trial protocol will be used to develop an emulated trial protocol, which will give the best approximation of the trial protocol, given the limitations and constraints of the observational data. to mimic an actual trial population, the target trial population will be matched with individual patient data from a historical trial, targeting the same population.
assessment of safety, tolerability, pharmacokinetics, and pharmacodynamics of apb-r3

Conditions: Still's Disease, Adult-Onset

Summary: this will be a single centre, phase 1, first-in-human, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending dose of apb-r3 in healthy participants.

primary objective of this study will be to evaluate the safety and tolerability of apb-r3 following intravenous (iv) administration of single ascending dose in healthy participants. the study will consist of 5 planned cohorts (1 cohort per dose level) for a total of up to 31 participants. cohorts 1 and 2 will include 5 participants each (3 participants receiving the active and 2 participants receiving the placebo). cohort 3 to cohort 5 will include 7 participants each (5 participants receiving the active and 2 participants receiving the placebo).

Eligibility criteria:
inclusion criteria: 1. male or female, non-smoker, 18 to 60 years of age (both inclusive), 2. healthy as defined by: 1. the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration in the opinion of the investigator. 2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease in the opinion of the investigator. exclusion criteria: 1. abnormal finding at physical examination 2. evidence of clinical significant hepatic or renal impairment 3. clinically significant abnormal laboratory test results or positive serology test results for hbsag, hcv antibody, or hiv antigen and antibody, or positive test results for covid-19, or quantiferon®-tb test at screening. 4. any reason which, in the opinion of the investigator, would prevent the participant from participating in the study.
fetal pulmonary vein and umbilical artery pulsatility indices as predictors of fetal growth restriction in diabetic and hypertensive pregnant women

Conditions: Intrauterine Growth Restriction

Summary: diabetic and hypertensive pregnant women attending at kasr alani for antenatal care were subjected to complete history taking. all the participants were scanned using b mode sonography to determine the fetal biometric parameters (bpd, hc, ac and fl).only umbilical artery pulsatility index (uapi) and pulmonary vein pulsatility index (pvpi) were measured in the study. uapi and pvpi were measured between 28 and 34 weeks of gestation at the first routine ultrasound scheduled.

diabetic and hypertensive pregnant women attending at kasr alani for antenatal care were subjected to complete history taking. all the participants were scanned using b mode sonography to determine the fetal biometric parameters (bpd, hc, ac and fl).only umbilical artery pulsatility index (uapi) and pulmonary vein pulsatility index (pvpi) were measured in the study. uapi and pvpi were measured between 28 and 34 weeks of gestation at the first routine ultrasound scheduled. the umbilical artery doppler examinations were conducted on a free-floating loop at the middle of the cord, away from its placenta and fetal abdominal insertion sites. the doppler angle was \ 95th percentile are as follows: at 28th wk. \> 1.35, 29th wk. \>1.32, 30th wk. \>1.29, 31stwk \>1.27, 32ndwk. \>1.25, 33thwk \>1.22 and 34th wk \>1.2 (adedo et al., 2022).

Eligibility criteria:
inclusion criteria: * pregnant women between 18 and 44 years. * gestational age: 28 - 34 weeks of gestation at time of examination (only women with confirmed ga by sure lmp and/or first trimester us scan). * singleton pregnancy. * hypertensive women (preexisting or gestational hypertension). * diabetic women (preexisting or gestational diabetes). exclusion criteria: * women with any medical disorder (apart from diabetes and hypertension). * women with multiple pregnancies. * women with inadequate ultrasound images (i.e., marked obesity). * women with fetuses with chromosomal abnormalities or congenital anomalies and other factors that could affect fetal growth. * unavailable perinatal outcome data
efficacy study of dialyzed leukocytes extracts to treat paediatric moderate atopic dermatitis

Conditions: Childhood Atopic Dermatitis

Summary: patients with atopic dermatitis treated with conventional treatment plus dialyzed leukocyte extracts (dle-oral transferon) as adjuvant, have better clinical outcome than patients treated only with conventional treatment.


Eligibility criteria:
inclusion criteria: * atopic dermatitis diagnosis by hanifin and rajka classification * dermatitis severity: moderate, according with scorad index. * patients without treatment of topical steroids or immunosuppressants in the last 3 weeks. * patients with "informed consent form" signed by both parents, or advisor. * patients 7 years old or older whom have signed the assent form exclusion criteria: * patient who were treated with topical, or systemic steroids and/or immunosuppressants and they cannot discontinue their treatment. * patients who lived far from the hospital and they could not go to the visits.

Keywords: dialyzable leukocyte extracts transferon atopic dermatitis
indirect comparison of tobramycin solution for inhalation versus aztreonam lysine for inhalation in the treatment of cystic fibrosis

Conditions: Cystic Fibrosis

Summary: matching-adjusted indirect comparison of tobramycin solution (tis) versus aztreonam lysine (azli) using tis patient level clinical trial data and azli aggregated clinical trial data from published literature.


Eligibility criteria:
inclusion criteria: * ≥ 6 years of age with a documented cystic fibrosis (cf) diagnosis, * moderate-to severe lung disease, * the ability to perform reproducible pulmonary function tests, * pseudomonas aeruginosa (pa) airway infection. exclusion criteria: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: cystic fibrosis
botulinum toxin for the management of chronic orchialgia

Conditions: Chronic Testicular Pain

Summary: the purpose of this research study is to determine if botox injections will provide relief from chronic testicular pain. in the study, the spermatic cord of particpants will be injected with either botox or a placebo of saline. botox is currently used to treat other urological conditions like overactive bladder and lower urinary tract problems. for these conditions, botox works by relaxing muscles in the affected areas. the investigators believe that botox will act similarly in the treatment chronic testicular pain.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic testicular pain (orchialgia) exclusion criteria: * active infection of urinary tract (uti) * active infection of the scrotal skin of the affected side * bilateral orchiectomy

Keywords: chronic testicular pain orchialgia botulinum toxin botox urology
clarithromycin resistant tailored therapy

Conditions: Peptic Ulcer; Helicobacter Pylori Infection

Summary: 1. back ground antibiotics resistance of helicobacter pylori, especially to clarithromycin is one of the main causes of failure of eradication. 23s rrna point mutation of helicobacter pylori is associated clarithromycin resistance 2. hypothesis if the investigators check the 23s rrna point mutation then choose treatment regimens containing a proton pump inhibitor and combination of two antibiotics (amoxicillin and clarithromycin or metronidazole), the investigators will eradicate helicoabacter pylori more successfully 3. material \& methods the investigators enroll patients diagnosed with peptic ulcer, endoscopically. helicobacter pylori is documented with urea breath test or silver staining biopsy specimen or polymerase chain reaction of biopsy specimen. check the 23s rrna a2142g/a2143g point mutation by polymerase chain reaction. if there is mutation, the investigators consider as resistance to clarithromycin and choose the treatment regimen containing a proton pump inhibitor, amoxicillin, metronidazole. if there is no mutation, choose the treatment regimen containing a proton pump inhibitor, amoxicillin, clarithromycin. verify helicobacter pylori eradication by urea breath test. compare eradication rate with conventional treatment,proton pump inhibitor, amoxicillin, clarithromycin.


Eligibility criteria:
inclusion criteria: * 20 - 75 years old * peptic ulcer (gastric ulcer, duodenal ulcer) * helicobacter pylori positive exclusion criteria: * major comorbidities * pregnancy * history of helicobacter pylori eradication * history of gastric surgery or other cancers, except to endoscopic treatment due to gastric lesion

Keywords: peptic ulcer helicobacter pylori clarithromycin 23s rrna resistance
pharmacokinetics with a new oral nicotine replacement product and nicorette® gum

Conditions: Tobacco Dependence

Summary: single-dose pharmacokinetics with a new oral nicotine replacement product and nicorette® gum.

the study is a single-dose, randomized, cross-over study. the investigational products will be given as single doses at separate visits. the product administrations comprise 30 minutes of chewing. periods without nicotine replacement therapy (nrt), lasting for at least 36 hours, will separate treatment visits. before and after the start of product administration at each treatment visit, blood will be sampled for pharmacokinetic analyses, pre-dose, and during 8 hours after start of product administration. used gums will be collected and analyzed to determine the amount of remaining nicotine. subjects will also be monitored to capture any adverse events that may occur. treatment labels will be concealed from subjects, study personnel, monitor, and analysts.

Eligibility criteria:
inclusion criteria: * healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and bmi between 17.5 and 30.0 kg/m2. * female participants of child-bearing potential are required to use a medically acceptable means of birth control. * a personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study. exclusion criteria: * pregnancy, lactation or intended pregnancy. * treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

Keywords: smoking cessation, nicotine pharmacokinetics
pharmacokinetics of multiple dose methadone in children treated for opiate withdrawal

Conditions: Opiate Withdrawal Syndrome

Summary: the purpose of this study is to learn more about how the study drug, methadone, prescribed by an infant's or child's physician as part of standard medical care, is processed in children and young adults. while this drug is used extensively in infants and children, it has not been extensively studied in this population. physicians do not have very much information on how long it takes for methadone to be removed from the blood circulation and passed out of the body. physicians need more information to guide how much and how often we should give methadone to children/young adults to ensure they get the maximum effect with the minimum amount of drug. during this research study, the study team will collect information about how this drug is processed in infants and children.

a total of approximately 24 to 36 infants and children will participate in this study. this study will be done at five medical centers in the united states. treatment will be prescribed by the infant or child's doctor and not by the study team. participants will be divided into 3 groups based on age, ages 3 months to 2 years, ages 2 to 6 years, and ages 6 to 18 years. there will be approximately 8 to 12 participants enrolled in each group. additionally, at least 6 overweight or obese participants between ages 2-18 years will be included in this study. information collected from each subject's routine medical care will include: * participant gender, date of birth, race and ethnicity * pertinent medical history * laboratory results (blood count and chemistries) from routine testing ordered by the infant or child's regular doctor * medications of interest the child was given within the 72 hours prior to first dose of methadone administered after consent * time and dose of methadone administered to the child up to 14 days prior to enrollment study specific information collected will include: * blood sample collection to measure level of methadone * baseline wat-1 score (sedation withdrawal assessment of the infant or child used to assess symptoms the child/infant may experience when opioid drugs are discontinued). the duration of the study will be up to 10 days, comprised of a maximum 5 day treatment period a 5 day observation period.

Eligibility criteria:
inclusion criteria: * \>90 days - \< 18 years of age at the time of first dose of study drug * receiving enteral methadone as standard of care * signed informed consent/hipaa documents by the parent/legal guardian and assent (if applicable) exclusion criteria: * previous participation in the study * subject is receiving ecls (extracorporeal life support) * \< 36 weeks gestational age at birth for children \<1 year of age at time of enrollment * any other condition or chronic illness that in the opinion of the principal * investigator makes participation unadvised or unsafe

Keywords: opiate withdrawal in children